BB&T
Delcath Systems (New York) has reached Phase III trials with its technology that facilitates ultra-high dose delivery of chemotherapy directly to the liver to treat liver cancer.
The Delcath System (DS) uses a minimally invasive procedure combined with a catheter technology to isolate the blood flow from the liver, allowing for the infusion of a bolus dose of chemotherapy while preventing systemic toxicities. The procedure is being tested at the U.S. National Cancer Institute in a Phase III trial for metastatic melanoma to the liver from ocular and cutaneous origin.
Delcath also has a Phase II trial for metastatic neuroendocrine tumors and adenocarcinomas to the liver, as well as primary liver cancer.
Both trials are using a 3 mg/kg dose of melphalan directly to the liver. and both are showing impressive and durable tumor responses, according to the company. Previous testing used a variety of drug agents, including doxorubicin and 5FU. Data generated from the Phase III pivotal trial will serve as the basis for seeking final FDA approval under a Special Protocol Assessment.
"We all know that systemic chemotherapy poisons the whole body," Richard Taney, president/CEO of Delcath, told Biomedical Business & Technology. "The DS is regional cancer treatment. It isolates an organ of the body and treats it with chemotherapy and then goes one step beyond by filtering the blood and returning it to the liver."
The main component of the system is a 16 Fr double balloon catheter inserted via the femoral vein and positioned within the retrohepatic inferior vena cava to isolate the hepatic venous outflow. Two independently-inflated low-pressure occlusion balloons are positioned to block the inferior vena cava above and below the hepatic venous outflow. When the balloons are inflated, isolating the venous outflow, fenestrations on the catheter allow the hepatic venous blood to exit through the catheter into an extracorporeal blood circuit.
Blood which exits from the proximal end of the catheter is pumped through two carbon filters before returning to the systemic circulation through the internal jugular vein.
Patients in the trials usually receive the treatment at four-week intervals and up to 10 treatments have been administered to a patient.
"We can administer chemotherapeutics over 30 minutes, and then we capture the blood exiting the liver — heavily doused with chemotherapeutics — run it through a filtration systems like a heart bypass, then return the cleansed blood," Taney said.
"The process is over in an hour. The pump is turned off, catheters are withdrawn. This can be administered once every 21 days. It's a repeatable therapy."
So far in the phase III trial, researchers are reporting 30% to 100% reduction in tumor volume and 50% response in patients.
"Our target patients have at least 20 tumors — a heavy tumor load — which would typically be treated by surgical resection," Taney said. "We are the only technology out there that can bathe the entire organ in chemotherapeutics. A patient receiving chemotherapy systemically would typically get .4 mg/kg of body weight. We can deliver a targeted regionalized does of 3 mg/kg.
"We're not simply stabilizing the disease, we are seeing dramatic reduction in tumor size if not complete responses," he added. "The gold standard in liver cancer is to cut it out. Ninety percent of cases are non-resectable. We can reduce tumor load and make non-resectable cases resectable."
While the company doesn't claim to be curing cancer with its DS, Taney said that, unlike surgically isolated hepatic perfusion (IHP) which can be performed only once, this procedure (percutaneous hepatic perfusion) can be administered repeatedly over an extended period, thus improving its life-saving potential.
"When people die of melanoma, they are dying of metastatic disease," he said. "But usually when it goes to the liver, it's a death sentence. We had a patient who had over 50% replacement of her liver with tumors. We cured her liver cancer, but she died 42 months later of brain cancer."
Delcath has filed the DS with the FDA as a class III medical device, not via 510(k) because there is no predecessor device. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with class III devices, general and special controls alone are insufficient to assure the safety and effectiveness of these kinds of devices. Therefore, DS will require the more stringent premarket application route.
Taney added that Delcath also has an investigational new drug application in the works because, even though they are working with FDA-approved chemotherapeutics, the dosages are extremely high.
The DS is Delcath's only product, and Taney points out that its potential applications for other diseases are broad. "Basically any drugs that have failed because of high systemic toxicity may be a candidate for DS," he said.
The company has enough funding for the immediate future, $19 million with a monthly burn of $500,000 and no outstanding debt.
The DS is comprised of parts that come from Medtronic (Minneapolis) and B. Braun (Bethlehem, Pennsylvania). Nothing is manufactured by Delcath.
Elsewhere in the product pipeline:
• American Bio Medica (ABMC; Kinderhook, New York) said that it has commenced manufacturing diagnostic test strips for Syphilis for Hema Diagnostic Systems (HDS; Miami Beach, Florida), a privately held manufacturer of rapid diagnostic tests for infectious diseases. HDS will incorporate the ABMC Syphilis test strip into HDS' Rapid 1-2-3 Hema Express delivery system. The Express is a patent pending device that provides a simple, efficient and cost effective method that allows testing at the point of care. The express uses instrumentation incorporating a simple, pre-marked series of lines on the sample pad, used to clearly identify when sufficient blood has been taken up onto the pad. This feature aids in eliminating guesswork and ensures reliable, repeatable test results.
• Arobella Medical (Minneapolis) said that it has launched the Qoustic Wound Therapy System, which uses low-frequency cavitational ultrasound for wound care, offering "an alternative to painful sharps debridement and other surgical modalities." The Qoustic assists healing by gently removing dead or diseased tissue cells and bacteria, leaving healthy and pre-healing granulation tissue intact and is also useful in preparing the wound bed for other therapies, such as grafts and flaps. Low-frequency ultrasound debridement is emerging as a preferred method of care for many types of wounds, including pressure ulcers, diabetic ulcers, infected wounds, burns and other chronic wounds. The system's dome-shaped Qoustic Qurette vibrates at 35 kHz, converting electrical energy to ultrasound waves and focusing them intensively on the wound. Sterile saline solution transfers the ultrasonic energy to the wound, where tiny vibrating gas bubbles and cellular-level fluid movement separate dead and harmful cells from healthy tissue. Arobella makes low-frequency ultrasound products.
• Ascension Orthopedics (Austin, Texas) said the Titan humeral resurfacing device is now available to help people who suffer from debilitating shoulder disorders. The company said the Titan "has advanced the concept of humeral resurfacing by offering a unique four-finned stem design that allows for greater purchase in the bone and enhanced stability." The resurfacing device provides a less-invasive option for the shoulder with a stable, anatomic implant. Ascension Orthopedics makes orthopedic implants for the hand, upper extremity and foot.
• AtriCure (West Chester, Ohio) reported that the first patient was successfully treated in AtriCure's ABLATE clinical trial. The purpose of the ABLATE clinical trial is to evaluate the safety and effectiveness of AtriCure's Isolator Synergy bipolar ablation system for reestablishing normal heart rhythm in patients with permanent atrial fibrillation (AF), requiring concomitant open-heart surgery using the Cox Maze IV procedure. The Isolator Synergy bipolar ablation system is designed to create precise lesions, or scars, on heart muscle, which block irregular electrical signals and restore normal sinus rhythm. AtriCure specializes in cardiac surgical ablation products.
• The Aurora Breast MRI Society (North Andover, Massachusetts) previewed the newly developed Aurora Breast MRI Society Global PACS Teaching Tool before an audience of more than 100 radiology professionals in attendance at the second annual Aurora Breast MRI Society Meeting. Unlike traditional PACS formats, the Teaching Tool will be the first PACS platform that will be exclusively used by a professional group, Aurora said. Members will be able to upload clinical cases and images without disclosing private patient information, interact with colleagues and extract images as needed to digitally exchange best practices and clinical knowledge, thus building a global Internet-based community for Aurora Breast MRI Society healthcare professionals to share experiences and insights. Aurora Breast MRI Society is a group of dedicated breast radiologists committed to advancing breast MRI technology.
• Biolase Technology (Irvine, California) reported receiving FDA clearance to market a version of its Waterlase MD Laser system for use in dermatological applications as well as general and plastic surgery. New indications for the device include incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing. In addition, general surgical use of the device is now allowed for incision, excision, vaporization and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated. Biolase is a dental laser company.
• Boston Scientific (Natick, Massachusetts) said that results of its defibrillator lead study, known as REFLEx, were published in the January issue of the journal PACE. The study compared the company's Endotak Reliance G Gore-coated leads to non-coated leads. Reliance G leads have a Gore ePTFE coating designed to prevent tissue in-growth. Tissue in-growth can make lead removal more difficult. Medical literature suggests up to 10 percent of leads may eventually need to be removed. A lead is an insulated wire that carries cardiac signals to the implanted device and also delivers energy from the device to the heart. In most cases, leads are passed into the heart through veins.
• CapsuleTech (Boston) reported that Trinity Health, the fourth-largest Catholic healthcare system in the U.S., will implement Capsule's DataCaptor connectivity suite at two of its hospitals. Trinity Health will be using the DataCaptor to automate the capture of patient data from bedside devices, including GE Monitors from the unity network. DataCaptor collects the data, converts it into HL7 format and integrates it into the hospitals' Cerner Millenium Clinical Information System (CIS). As one of the largest Cerner clients, with 43 hospitals in its network, Trinity Health will be implementing DataCaptor at Battle Creek Health System (Battle Creek, Michigan) for Cerner's SurgiNet OR solution and at Holy Cross Hospital (Silver Spring, Maryland) for Cerner's INet ICU solution. CapsuleTech makes connectivity solutions for healthcare institutions.
• CollaborateMD (Orlando, Florida) reported the introduction of CollaborateEMR, an Internet-based electronic medical record (EMR) software. The new service was developed in partnership with Sevocity, a division of Conceptual MindWorks (San Antonio, Texas), and will be integrated with CollaborateMD's practice management solution. An Internet-based EMR solution, Sevocity eliminates the expensive upfront capital expenditures and ongoing maintenance costs associated with client/server offerings. CollaborateMD provides Internet medical billing software for physician offices and medical billing services.
• Concordia Medical (Coventry, Rhode Island) reported the first clinical uses of Biofelt, a non-woven biomaterial which can readily be absorbed by the human body. Concoridia said that two of its medical device customers have separately received approvals to proceed with human clinical uses of products based on Biofelt in the urological and dental implant markets. Biofelt, a bioabsorbable polymer fiber scaffold that is porous, soft and flexible, biocompatible and enables human cells to grow into its 3-D interconnected pores so that new natural tissue can be formed to replace and/or repair damaged human tissues. Biofelt has been used in numerous leading biomedical research laboratories around the world for various advanced tissue engineering applications in the field of regenerative medicine. Biofelt is produced from medical grade polyglycolic acid and poly-L lactic acid and can be formed into various size sheets, discs, and tubes. Thicknesses can be specified from 0.3 to 7 mm and the bulk density from 30 to 300 mg/cc. Finished scaffolds are scoured, vacuum-sealed in moisture barrier foil pouches and packed with desiccant. Concordia Medical makes fiber based medical implants and scaffolds for regenerative medicine.
• Covidien (Boulder, Colorado) reported the introduction of a continuous, positive airway pressure (CPAP) device with an integrated heated humidifier. The Sandman Intro CPAP device is designed for a broad range of patients and provides continuous positive airway pressure and heated humidification. Travel-friendly features include the ability to run on AC/DC or external battery power and an altitude compensation feature that automatically adjusts pressure up to 9,000 feet of elevation, and compensates for changes in barometric pressure to preserve a patient's prescribed settings. Covidien makes CPAP and other sleep therapy devices and accessories.
• Cynosure (Westford, Massachusetts) reported the introduction of three aesthetic products for fast-growing applications including laser lipolysis, the removal of pigmented lesions and ablative skin resurfacing. The new products are SmartSense for Smartlipo, Accolade and Affirm Er. SmartSense is a handpiece delivery system for Smartlipo, Cynosure's minimally invasive system that liquefies and removes localized deposits of fat and results in tissue tightening through tissue coagulation. Accolade is a 755 nm, Q-switched Alexandrite laser for the removal of pigmented lesions. The unique combination of various spot sizes and the laser's high repetition rates allow for rapid treatment. The Affirm Er is a 2940 nm wavelength, Erbium: YAG laser for ablative skin resurfacing applications, such as the treatment of deep lines and wrinkles. Cynosure makes light-based aesthetic treatment systems.
• Cylex (Columbia, Maryland) reported the publication of an independent, peer-reviewed, cresearch study in which the level of cellular immune response measured prior to kidney transplantation using the company's ImmuKnow immune cell function test was found to identify patients that may be at risk for early acute transplant rejection and unstable kidney function in the first three months following transplantation. Cylex's ImmuKnow immune cell function assay detects cell-mediated immunity by measuring the concentration of ATP from CD4+ cells following stimulation. The assay is used for the detection of cell-mediated immunity in an immunosuppressed population. Cylex is a life science company that develops and manufactures research and in vitro diagnostic products that are intended to illuminate immunity.
• CytoCore (Chicago) said that FDA has approved the company's 510(k) clearance for its SoftPAP cervical cell collector. The company said that the SoftPAP "collects more comprehensive and complete cervical cell specimens for Pap testing. CytoCore's SoftPAP cervical cell collector is a significant advance in women's health," said Robert McCullough, Jr., CytoCore's CEO. "Each year, over 2 million American women are told that their Pap test was negative when, in fact, they have early stage cervical cancer. These false negatives are frequently caused by an inadequate or incomplete sample of cervical cells. SoftPAP collects complete specimens from the cervical canal, the cervical surface and the transition zone simultaneously" The company cited evidence "that the SoftPAP significantly reduces the rate of false negative Pap tests leading to earlier treatment of cervical cancer."
• diaDexus (South San Francisco, California) reported FDA clearance for an automated version of its PLAC Test. The new PLAC format, based on immuno-turbidimetric technology, is an automated immunoassay designed to run on common existing laboratory equipment, including clinical chemistry analyzers from Hitachi, Roche/Hitachi, and Olympus. The PLAC test is a blood test that measures lipoprotein-associated phospholipase A2 (Lp-PLA2), an enzyme specific to vascular inflammation implicated in the formation of rupture-prone plaque. The PLAC Test is the only blood test cleared by the FDA to aid in assessing risk of both coronary heart disease and ischemic stroke associated with atherosclerosis. diaDexus is a privately held company focused on the development and commercialization of novel, patent-protected diagnostic products with high clinical value.
• Focus Diagnostics (Cypress, California) reported the first laboratory-developed test in the U.S. for detecting the mosquito-borne chikungunya virus. Commercial availability of the molecular polymerase chain reaction (PCR) test will enable physicians in the U.S. to test patients who may have contracted the virus, such as individuals returning from regions in Africa and Asia where chikungunya is endemic. The chikungunya virus test is a molecular assay that employs PCR, a highly sensitive and commonly used testing method that can detect the presence of the virus' RNA in a patient's blood. Physicians can use test results in conjunction with clinical symptoms to diagnose a patient's infection with the virus. Until now, testing for chikungunya virus was not commercially available in the U.S. and specimens were referred to a public health laboratory, which could take a week or more to report results. Focus said it expects to be able to provide physicians with test results within a day of receiving a sample for testing. Focus Diagnostics is an infectious disease diagnostics company.
• Global Med Technologies (Denver) reported FDA clearance for ElDorado Donor — a new blood management product produced by its Wyndgate Technologies division. The ElDorado Donor is intended as a comprehensive blood management software application created to provide for the information system needs of blood bank and donor centers. The software is designed to manage, automate, and control activities associated with donors, donor collections, testing, manufacturing, inventory, and distribution. ElDorado Donor was developed with scalability in mind and is designed to manage the system needs of diverse facilities, from small hospital blood banks to community blood centers, to regional and national centers. Using an integrated modular configuration, ElDorado Donor is intended to offer functionality with flexibility to tailor features within the system to a facility's specific needs supporting process control from collection to distribution. Global Med is an e-health medical information company.
• Healthcare Providers Direct (Lawrenceville, New Jersey) reported the release of ImmunoDip, a rapid screening test to detect microalbuminuria, an early indicator of chronic kidney disease in diabetic patients. Microalbuminuria occurs when a malfunctioning kidney leaks small amounts of albumin into the urine. Sometimes early kidney damage can be reversed, making early diagnosis critical. ImmunoDip can detect as little as 18 mg/l of albumin in the urine. Microalbuminuria is indicated at 20-30 mg/l. With ImmunoDip, physicians can complete the test in their office with a negative or positive indication within three minutes. Healthcare Providers Direct makes rapid diagnostic tests.
• HealthSonix (Irvine, California) said that it is has approved the final sample of its second generation enSonix medical device. The enSonix personal treatment device has been indicated for pain reduction and muscle relaxation. "With this new medical device, we offer our customers affordable, effective arthritis pain relief without side effects. Patients can use it in the comfort of their own homes. The enSonix therapy is especially effective when used in combination with the most popular pain relievers. There is an incremental therapeutic benefit when you combine therapies," said Dieter Doederlein, VP of corporate development. The sound pressure waves generated by the enSonix medical device are believed to work in three ways: they stimulate mechanoreceptors in the skin, which in turn communicate with the brain and block pain messages from getting through (the gate control theory of pain); they create an exercise effect in the muscles, which encourages the production and release of endorphins, the body's natural pain killers; and increase in blood circulation. HealthSonix makes products that deliver sound pressure waves to the human body for relief of pain and other musculoskeletal conditions.
• HemCon Medical Technologies (Portland, Oregon) reported the availability of its hemorrhage control dressing, ChitoFlex, to acute care professionals in two smaller sizes, 1"x 3" and 3"x 9" strips. HemCon said its decision to expand the ChitoFlex product line was the result of feedback asking for additional product flexibility for varying wound sizes. The original ChitoFlex dressing, which comes in a roll and measures 3" x 28", will remain available for purchase. A two-sided, stuffable wound dressing, the ChitoFlex family of products is made from chitosan, a natural substance found in shrimp shells. The shrimp shells are processed, chemically treated, made into bandage form and then sterilized. ChitoFlex dressings control severe bleeding within two to five minutes by becoming adherent when in contact with blood. The adhesive-like action seals the wound and attracts red blood cells to the dressing, forming a seal that stops hemorrhaging independent of the body's natural clotting process. The dressings are antibacterial and effective on high-pressure, high-flow arterial bleeds.
• HepaLife Technologies (Boston) reported results from new in vitro studies in which the company's patented PICM-19 liver stem cells were placed inside its proprietary bioartificial liver device and were able to successfully and quickly remove high levels of toxic ammonia within a very short period of time. When challenged with high amounts of toxic ammonia, present in patients with acute liver failure, HepaLife's bioartificial liver reduced ammonia levels by 75% within less than 24 hours. Published in vivo clinical data of other systems using liver cells other than HepaLife's patented PICM-19, have only reported ammonia reduction levels from zero percent to 44%. During these same tests HepaLife's PICM-19 liver stem cells inside the company's bioartificial liver maintained differentiated hepatic (liver) function, showing typical hepatocyte morphology — the characteristics representative of human liver cells — including cell features such as intercellular canaliculi, extensive Golgi apparatus, endoplasmic reticulum, peroxisomes and mitochondria. HepaLife makes cell-based medical technologies addressing prevalent human health concerns.
• Hologic (Bedford, Massachusetts) reported the publication of a large-scale breast screening trial comparing a single radiologist using computer-aided detection (CAD) to double reading without CAD. The study compared the recall rate, sensitivity, positive predictive value, and cancer detection rate for single reading with CAD, versus double reading without CAD. Biopsy and pathology data for positive cases were also compared. The efficacy of screening mammography is enhanced when sensitivity is high and the recall rate is low. Double reading, though used by few practices in the U.S., is a method for increasing sensitivity commonly used in European screening programs. CAD has become increasingly popular as an alternative way to increase sensitivity, since double reading is time-consuming and because of a shortage of radiologists. CAD has the potential to increase sensitivity of screening mammography by marking areas of interest that might otherwise be overlooked by interpreting radiologists. However, CAD also may place false marks, identifying areas of suspicion that are not cancer. A small fraction of false marks may result in unnecessary patient recalls for further evaluation. The major goal for CAD is to reduce oversights when screening mammograms are read; the radiologist is still responsible for lesion analysis and final interpretation of an examination. Hologic makes imaging systems, diagnostics and interventional devices for women.
• IDEV Technologies (Houston) received FDA clearance for a new Supera biliary stent delivery catheter. The improved Supera is indicated for the palliative treatment of biliary strictures produced by malignant neoplasms. The Supera offers a retrieval capability of up to 95% for a partially deployed Supera biliary stent. The Supera offers more than 360% greater radial force than other commercially available laser cut nitinol tube self-expanding biliary stents. IDEV makes minimally invasive stent technologies.
• Ikonisys (Dallas) said that it has begun a clinical trial evaluating its breakthrough test for early detection of chromosomal abnormality trisomy 21. Early, non-invasive detection of genetic disorders, including Down syndrome, provides pregnant women with fast and accurate solutions that eliminate the need for repeat testing. The trial is intended to establish accuracy and efficacy in the detection of trisomy 21 in circulating fetal cells. Ikonisys expects this solution to be the first in a suite of non-invasive cell-based fetal tests. Ikonisys makes non-invasive, cell-based diagnostic solutions.
• Innocoll (Ashburn, Virginia) said that the second of two Phase 3 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies, to investigate CollaRx Gentamicin Surgical Implant for the prevention of surgical site infections, has commenced dosing. The implant is a fully biodegradable, leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. It is designed to provide a high concentration of gentamicin (which has a concentration-dependent mechanism of action) directly to the target tissue for localized action, while maintaining low systemic levels well below the toxicity threshold. The product was developed using Innocoll's collagen-based drug delivery technology, CollaRx, and is indicated as an adjunct to systemic antibiotic therapy for the treatment of localized, deep tissue infections and the prevention of surgical site infections in both hard and soft tissues.
• Life Spine (Hoffman Estates, Illinois) FDA clearance to market the Kinetic-SL, an internally dynamized anterior cervical plating system. The plate, with an exceptionally thin profile as well as a narrow plate width (16mm), was created from the clinical need to address small stature patients. Kinetic-SL features 0-2mm of fully adjustable internal dynamization per level and an ultra slim pre-lordosed profile. Plate sizes range from 21mm to 111mm, in levels one to five. The Kinetic design allows for generous screw angulation, as well as a large graft window, a feature which competitive products do not have. Life Spine improves the quality of life for spinal patients by increasing procedural efficiency and efficacy through design and manufacturing platforms.
• Kinetic Concepts (KCI; San Antonio) has introduced a new mattress replacement system (MRS), the AtmosAir V-series MRS, designed to assist hospitals in the prevention and treatment of pressure ulcers. According to the company, the V-series MRS enhances the AtmosAir family of surfaces, which already accommodates a wide range of hospital bed frames and stretchers, by adding compatibility with the Hill-Rom VersaCare frame. The AtmosAir V-series works automatically, keeping patients at an appropriate level of pressure redistribution with no power or patient adjustment required, KCI said. The company makes advanced wound care products and therapeutic surfaces.
• Medical Safety Technologies (McAllen, Texas) reported introduction of its new Turtle SafeShot Safety Syringe, the only passive, self-sheathing syringe never exposing the needle during the entire injection process. The syringe uses a design to ensure that the needle is never exposed from the moment the syringe is taken from its original packaging, through the injection process and finally to sanitary disposal. The syringe's design includes a hard, shatter-resistant and unbreakable sheath on the outside of the needle, which stays intact. A spring-loaded mechanism keeps the sheath constantly against the medication source or patient, in such a way that the needle is never exposed to the user. It is currently available in 3 cc size.
• Medtronic (Minneapolis) reported FDA approval of a new physician-use continuous glucose monitoring (CGM) system, the CGMS iPro Recorder. Physicians send patients home with the CGMS iPro to uncover patterns and potential problems that often go undetected with today's standard glucose measurements like finger stick meters and HbA1c tests. Patients wear the CGMS iPro Recorder for three days, after which physicians can review the data and use the results to uncover glucose patterns and optimize patient therapy. The iPro is attached to a small glucose sensor inserted just under the skin. During the course of three days, the recorder automatically measures and stores glucose values during daily activities like work, sleep, eating, and exercise. After the recording period is completed, the patient returns to the physician's office where the device is removed and downloaded.
Medtronic also reported receiving FDA approval for the RestoreUltra neurostimulation system for the treatment of chronic intractable pain of the trunk and/or limbs (chronic back and leg pain). This rechargeable neurostimulator is the smallest and thinnest 16-electrode rechargeable neurostimulator available. The patient programmer used with the RestoreUltra system gives patients more control over their therapy than ever before. In addition, the RestoreULTRA neurostimulator allows patients who use medium stimulation settings to go at least two weeks before needing to recharge. Medtronic's neuromodulation business offers therapies for chronic pain, movement disorders, spasticity, overactive bladder, benign prostatic hyperplasia and gastroparesis.
• MedWaves (San Diego) received FDA clearance for its patented microwave coagulation/ablation system for general surgery use for the coagulation and ablation of soft tissues. The system is comprised of a microwave generator and single patient use sterile devices. The system offers potential advantages over RF thermal ablation methods in the following ways: consistency and predictability of lesion creation; ability to treat large lesions (over 3 cm); increased safety due to the elimination of grounding pads and the resultant skin burns due to poor contact; and more even distribution of the thermal energy delivery in the tissues that is not dependent upon low impedance paths that can be unpredictable. MedWaves makes microwave ablation technology.
• Micro Power (Beaverton, Oregon) said that it designed and manufactured a new, custom Li-ion battery pack specifically for the latest point-of-care ultrasound systems from SonoSite (Bopthell, Washington), the M-Turbo hand-carried system and the S Series ultrasound tools. Micro Power's new battery pack not only powers SonoSite's new, fourth-generation systems, but it is compatible with existing SonoSite products such as the MicroMaxx and TITAN systems. The battery pack provides over 60 Watts of power, 15% more power than current battery packs offered with SonoSite products. The battery pack was designed to support SonoSite's requirements for uncompromised performance, immediate boot-up from a cold start and extended sessions of use within a lightweight unit. Micro Power makes portable power systems for mission-critical equipment.
• Mitralign (Tewksbury, Massachusetts) said that it performed its first implantation of the Mitralign percutaneous annuloplasty system for mitral valve repair at French Hospital (Asuncion, Paraguay). The Mitralign was able to remodel the valve and reduce the patient's mitral regurgitation (MR) from 3+ to 2+, 24 hours after the procedure, based on lab assessment. The patient spent less than 48 hours in the hospital after the procedure and continues to do well at home, Mitralign said, the system emulating the open surgical procedure of suture-based mitral annuloplasty. The implant was delivered percutaneously though a single 14 Fr femoral arterial sheath, providing direct geometric reduction of the posterior annulus. Mitralign is developing a catheter-based methods to treat MR in patients suffering from congestive heart failure.
• Multi Radiance Medical (Solon, Ohio), in partnership with Rich-Mar (Chattanooga, Tennessee), reported the introduction of its new therapeutic laser, Laser Prism with area identification matrix and its FDA-cleared LaserStim accessory, to speed relief to chronic and acute pain sufferers. Laser Prism's specially designed LaserStim accessory can provide simultaneous or independent light and electrical stimulation applications for superior clinical applications and outcomes. In addition to its proven pain-relieving qualities, physical therapists and chiropractors can now be reimbursed for the time spent administering light therapy. The LaserStim is a combination emitter that uses multiple radiances, including a super-pulsed laser with 25,000 milliwatts of peak power, red LEDs, infrared and static magnetic field, with electrical stimulation to promote an optimal healing environment. Laser Prism and LaserStim provide temporary relief of minor muscle and joint pain, arthritis and muscle spasm. Rich-Mar specializes in ultrasound, electrotherapy, and light therapy modalities. Multi Radiance makes devices using multi radiance technology.
• Natus Medical (San Carlos, California) said that the FDA has approved its supplement to the premarket approval application for the Olympic Cool-Cap. The Cool-Cap is used for treatment of hypoxic ischemic encephalopathy (HIE) in term newborns. The system provides selective head cooling to prevent or reduce the severity of neurologic injury associated with HIE. Roughly three in 1,000 newborns are at risk of brain injury due to an interruption of blood flow and oxygen supply during labor and delivery. In 1999, the company's Olympic Medical division initiated a four-year international multi center study of the Cool-Cap system. Results of the study confirmed that when head cooling therapy was administered to patients within the first six hours of life, the severity of brain injury was significantly decreased compared to the untreated control group. Natus is a makes healthcare products used for the screening, detection, treatment, monitoring and tracking of common medical ailments such as hearing impairment, neurological dysfunction, epilepsy, sleep disorders, and newborn care.
• Nikon Instruments (Melville, New York) launched the A1 series of confocal laser point scanning systems, which integrates with the new Ti-E research inverted microscope. The fully-automated confocal imaging system captures high-quality confocal images of cells and molecular events at high speed and enhanced sensitivity. Two models are available: the A1 and the A1R. The A1 offers standard paired galvanometers with high resolution scanning at up to 4096 X 4096 pixels, with a standard speed of two frames per second (fps) for 512 x 512 pixels. The A1R model incorporates a hybrid scanner system of paired galvanometers coupled to a high speed resonant galvanometer. Nikon Instruments specializes in advanced optical technology.
• Ocean Optics (Dunedin, Florida) reported the introduction of the RedEye Oxygen Patch. Using a combination of sensing material and optical sensing technologies, the non-invasive patch enables quick readings of the presence or absence of oxygen, as well as provides quantitative measurements. The self-adhesive RedEye patch can be integrated into the surface of sample containers such as blood bags, pill blister packs, or point of care analysis devices like disposable ventilator oxygen attachments, to permit non-invasive, through-the-package oxygen concentration measurements. RedEye coatings are capable of monitoring low levels of oxygen in gas (to 0.005%) and dissolved oxygen in liquids (to 20 ppb), as well as the higher oxygen levels present in cell culture and respiratory monitoring. In addition to medical and pharmaceutical uses, RedEye coatings are available for food, beverage, fuel and other hydrocarbon-based product applications. Ocean makes miniature photonics.
• OrbusNeich's (Hong Kong) Genous bio-engineered R stent is feasible and safe for use in acute myocardial infarction (AMI) patients, according to a paper published in the American Heart Journal. Unlike drug-eluting stents, Genous, which is coated with an antibody, captures a patient's endothelial progenitor cells (EPCs) to accelerate the natural healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. When attracted to the surface of Genous, EPCs rapidly form an endothelial layer over the stent that provides protection against thrombus and minimizes restenosis. OrbusNeich makes medical devices for the treatment of vascular diseases.
• Orqis Medical (Lake Forest, California) said that the company's MOMENTUM Trial Abstract was accepted for Late Breaking Clinical Trial presentation at the upcoming (March) annual meeting of the American College of Cardiology (Washington) in Chicago. MOMENTUM evaluated the percutaneous Cancion System in patients with acute decompensated heart failure. "MOMENTUM is a landmark study examining the hemodynamic and clinical effects of the Cancion System in managing patients hospitalized with heart failure inadequately responsive to medical therapy," said Barry Greenberg, MD, who will present the abstract. Orgis makes products for treatment of heart failure.
• Palomar Medical Technologies (Burlington, Massachusetts) reported the introduction of two new fractional hand pieces. The Lux2940 fractional ablative laser handpiece is a single-treatment skin resurfacing device which allows the practitioner to tailor the level of skin tightening based on the patient's needs. The microfractional technology preserves portions of healthy tissue surrounding the treatment zone, fostering unprecedented rates of reepithelialization and lower patient downtime, with significantly less pain than traditional ablative laser procedures. Palomar's other new handpiece, the Lux1440, is a fractional, non-ablative skin resurfacing handpiece that operates much like the popular Lux1540(TM), but with faster treatment times. Specifically, licensed practitioners are performing effective full-face treatments in about 12 minutes. Palomar makes light-based treatments for cosmetics treatments.
• Rapid Product Development Group (RPDG; San Diego) reported the addition of a new stereolithography resin from DSM Somos (Elgin, Illinois) brand-named WaterClear Ultra. RPDG says that WaterClear combines clarity with low color, high dimensional accuracy and other performance features. It is designed for the production of lenses, housings, packaging models, fluid flow analysis models and master patterns. Miguel Diaz, director of Mexico Manufacturing Operations for RPDG, said, "The WaterClear Ultra material is by far the clearest SLA material I have seen. It also builds very well and offers great accuracy." RPDG makes products for the healthcare, automotive, computer, consumer products and industrial equipment industries.
• Reliant Technologies (Mountain View, California) reported the launch of its Fraxel repair laser system to the dermatology community. The Fraxel re:pair laser is a minimally invasive, ablative fractional laser system that delivers a full spectrum of aesthetic treatment from fractional microderm ablation treatment to fractional deep dermal ablation treatment. It can be operated by a single clinician, because of its built-in smoke evacuation system, and is capable of treating at depths from 300 micrometers ( m) to 1.6 mm into the dermis. Reliant Technologies makes fractional resurfacing and aesthetic laser skin treatments.
• Rubbermaid Medical Solutions (RMS; Huntersville, North Carolina) reported the launch of the Mini Med Module with mounting bracket for the motion computing C5 mobile clinical assistant (MCA). Key features for the mini med module include: compact 14" wide base enables cart to easily get to point of care, electronic PIN code locking medication drawers with a timed auto-locking feature, and a large bottom drawer for storing supplies or the C5 MCA when it is not in use. Rubbermaid Medical Solutions makes medication carts and mobile computing solutions.
• Siemens Medical Solutions' Oncology Care Systems unit (Concord, California) received FDA clearance for the sale and distribution of its most recent innovation in radiation therapy technology, the Artiste solution. The Artiste is a linear accelerator engineered specifically for adaptive radiation therapy (ART). This radiation therapy solution offers clinicians multiple imaging modalities. From Megavoltage (MV) to gold-standard, in-room CT imaging, clinicians can select the optimal imaging application for their treatment approach. Siemens' MVision cone beam imaging package delivers outstanding soft-tissue resolution, especially in challenging cases, such as imaging prostheses and with large patients. The CTVision CT-on-rails system provides in-room, diagnostic quality.
The company's Oncology Care Systems unit (Concord, California) reported receiving FDA clearance for its Artiste solution, a linear accelerator engineered specifically for adaptive radiation therapy (ART). This radiation solution offers clinicians multiple imaging modalities, from Megavoltage (MV) to gold-standard, in-room CT imaging. Siemens' MVision cone beam imaging package delivers outstanding soft-tissue resolution, especially in challenging cases, such as imaging prostheses and with large patients. The CTVision CT-on-rails system provides in-room, diagnostic quality imaging, thus opening up opportunities to implement benchmark concepts, such as daily re-planning.
• Smiths Medical ASD (Rockland, Massachusetts) said it has received FDA clearance for its Saf-T closed blood collection system for use in syringe blood draw and transfer applications. Configurations address winged vein access as well as Luer access to a newly placed peripheral IV catheter. The Saf-T is similar in design to Saf-T Wing blood collection set, but accommodates either a male Luer connector or a Saf-T Wing to access the vein. Both configurations use a female Luer connector for sample syringe attachment. The company said the Saf-T devices require minimal manipulation of the Luer connectors once the initial set up is completed, resulting in lower risk for sample contamination. Smiths Medical specializes in safety devices, vital care and medication delivery and patient monitoring.
• St. Jude Medical (St. Paul, Minnesota) said that it has distributed a programmer software upgrade to eliminate a random, low-frequency anomaly that could affect ventricular sensing in the Epic and Atlas families of implantable cardiac defibrillators. Specifically, a potential loss of ventricular sensing has been attributed to an extremely rare timing sequence that occurs in a very small (61 microsecond) timing window. To date, an incidence of 0.00006 of the subject device population (eight out of around 143,000 implanted since July 2002) has been found to exhibit a loss of ventricular sensing. The new software will be downloaded into the device during a patient's next routine check up and will fully prevent the anomaly from occurring in the future. The non-invasive software upgrade can be completed in approximately 10-20 seconds, during which time the device will maintain full functionality.
• T2 Biosystems (Cambridge, Massachusetts) reported significant research findings that support the advancement and development of nanoparticle-based MRI technology that offers rapid, portable diagnostic testing. This research demonstrates new methods of advancing and developing magnetic resonance-based diagnostics that offer improved speed, accuracy and efficiency as well as portability to a broader range of settings including doctor's offices, homes and hospitals. These findings show the feasibility of T2's portable diagnostic system, building on dozens of prior published research studies by scientists demonstrating the ability of the nanoscale MR-based technology to detect target substances in diagnostic tests, including small molecules, single viral particles, bacteria and cancer biomarkers. T2 Biosystems makes portable diagnostic products.
• Thermage (Hayward, California) introduced its ThermaTip CL treatment tip and its cellulite procedure at the American Academy of Dermatology meeting in San Antonio. The procedure uses the company's ThermaCool system for the temporary improvement in the appearance of cellulite. The advanced deep-heating ThermaTip CL is designed to rebuild collagen connective tissues and improve blood flow to the tissue, helping to improve the smooth appearance of the skin's surface, Thermage said.
• TomoTherapy (Madison, Wisconsin) said it has begun shipping a faster version of its proven platform for image-guided, intensity-modulated radiation therapy (IG-IMRT). Version 3.1 of the TomoTherapy Hi-Art treatment system includes new software and hardware features that enhance clinical productivity and system usability, and are expected to increase patient throughput. Software highlights of Hi-Art version 3.1 include a variety of delivery system design improvements that eliminate delays in the treatment process. Hardware updates include the addition of a second planning workstation to facilitate parallel clinical workflow, and the introduction of the new high performance couch, which provides efficiencies in the quality assurance, imaging and treatment processes. TomoTherapy makes radiation therapy systems.
• Technology4Medicine (San Clemente, California) and A.R.C. Laser (Nürnberg, Germany), a producer of high quality medical lasers, said the FDA has granted clearances for the FOX diode dental lasers. Technology4Medicine, in partnership with A.R.C., is offering the FOX lasers in the broadest range of wavelengths available including 810nm, 980nm or 1064nm to meet the specific clinical needs of the U.S. dental and hygiene community. Technology4Medicine, and its dental laser division, Lasers4Dentistry, makes lasers and other advanced high technology products for the dental, medical, veterinary and physiotherapy markets.
• Toshiba America Medical Systems (Tustin, California) reported FDA clearance for its new open-bore 1.5T vantage titan MR system. The company said the open-bore of the titan is 18% larger than other 1.5T systems on the market, featuring a large 71-centimeter patient aperture. The system features Toshiba's Pianissimo noise reduction technology, which creates a better imaging experience for all patients. The titan also takes advantage of Toshiba's contrast-free MRA techniques – fresh blood imaging, contrast-free improved angiography, time-spatial labeling inversion pulse, and time-slip angiography. Toshiba America Medical makes magnetic resonance technology.
• Valor Medical (San Diego) said that approval for the first clinical trial in Europe has been received. The technology that Valor developed, Neucrylate, is a liquid that is injected into a cerebral aneurysm through a micro-catheter placed from the femoral artery. When Neucrylate comes in contact with blood, the liquid changes into a solid material similar to a sponge. The surgical procedure for injecting Neucrylate will take less time, yet offers a more complete filling of the aneurysm as compared to coiling.
• Varian Medical Systems (Palo Alto, California) reported a series of educational symposia about its revolutionary RapidArc radiotherapy technology for faster and more precise cancer treatments. These symposia offer clinicians the opportunity to learn more about a technology that makes it possible to deliver image-guided, intensity-modulated radiation therapy (IMRT) two to eight times faster than is possible with conventional IMRT or helical tomotherapy. Varian makes devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, proton therapy, and brachytherapy.
• Volcano (San Diego) reported FDA clearance of the s5-Revo and s5-FFR (fractional flow reserve) options. These product offerings now enable rotational IVUS and FFR to operate on the same integrated Volcano s5 imaging system as Volcano's previous line of phased array IVUS catheters and functionality. For the first time, physicians can choose among three powerful diagnostic tools • all on the same integrated IVUS platform. Earlier generation consoles included only one of the three technologies now available on the s5. If a hospital wanted to equip a new lab with all three technologies, they would have to acquire three separate consoles, each with a different measurement modality, training requirements and data storage protocols. Volcano says that the s5 system can accommodate the three primary intravascular diagnostic tools in regular use by cardiologists today (high frequency rotational IVUS, fast and simple digital IVUS, and pressure-based FFR guidewires) on a single platform.
• Welch Allyn (Skaneateles Falls, New York) introduced the Digital MacroView Otoscope, a hand-held video otoscope with USB connected, plug-and-play capabilities that offers clear, live and still images of the ear canal and tympanic membrane•improving communication and patient compliance. The Digital MacroView Otoscope has the ability to focus the image for clear views, comes equipped with an insufflation port for pneumatic otoscopy, and works with all existing Welch Allyn 3.5V power sources.
• Wright Medical Group (Arlington, Tennessee) reported a limited launch of its Biofoam Cancellous Titanium Tibial Base, the latest addition to its Advance knee systems. The Biofoam features bone-like titanium with a roughened texture that "bites" into bone for cementless fixation of the impant, according to the company. Wright makes reconstructive joint devices and biologics.
Wright also reported new product and technique innovations for its line of solutions for hip surgery. The introductions include the company's first cemented modular neck hip implant, a new revision stem that combines wedged-stem design with modular neck technology, and a total hip arthroplasty surgical technique that does not require the hip to be dislocated during the procedure. The Supercar technique for total hip arthroplasty was developed by Stephen Murphy, MD, of New England Baptist Hospital (Boston). The goal of this approach is to safely perform total hip arthroplasty while minimizing the effects on the surrounding soft tissues. this approach does not require surgical dislocation of the hip during the procedure, resulting in maximum preservation of the surrounding soft tissue. The technique is performed through a single incision, helping to reduce patient recovery times for a quicker return to regular activities.